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A 510(k) is a premarketing submission made to FDA to demonstrate that the device to be marketed is as safe and effective, that is, substantially equivalent (SE), to a legally marketed device that is not subject to premarket approval (PMA). 510(k) (premarket notification) to FDA is required at least 90 days before marketing unless the device is exempt from 510(k) requirements.

Premarket Approval (PMA) is the most stringent type of device marketing application required by FDA. A PMA is an application submitted to FDA to request approval to market. Unlike premarket notification, PMA approval is to be based on a determination by FDA that the PMA contains sufficient valid scientific evidence that provides reasonable assurance that the device is safe and effective for its intended use or uses.

Regulation also provides for the submission of a humanitarian device exemption (HDE) application. A Humanitarian Use Device (HUD) is a device that is intended to benefit patients by treating or diagnosing a disease or condition that affects fewer than 4,000 individuals in the United States per year. The (HDE) application is similar in both form and content to a premarket approval (PMA) application, but is exempt from the effectiveness requirements of a PMA.

The Food and Drug Administration Modernization Act of 1997 (FDAMA) added the de novo classification option, which is also known as Evaluation of Automatic Class III Designation. This option provides an alternate pathway to classify novel devices of low to moderate risk. Devices that are classified through the de novo process may be marketed and used as predicates for future 510(k) submissions.